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Kulzer, Inc.

Last updated September 17, 2026

What Kulzer, Inc. makes

Kulzer, Inc. manufactures dental materials including resin artificial teeth, dental composite resins, veneer resins for prostheses, polyether impression materials, and laboratory CAD/CAM dental milling systems. Their portfolio also includes dentine bonding agents and specialized dental resins for restorative and prosthetic applications.

The company’s products are classified as Class II medical devices and are listed in the FDA’s Unique Device Identifier (UDI) database. Kulzer, Inc. is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Kulzer, Inc. manufacture?

Kulzer, Inc. specializes in dental materials and systems. Their portfolio includes resin artificial teeth, dental composite resins, veneer resins for dental prostheses, polyether impression materials for dental impressions, and laboratory CAD/CAM dental milling systems. They also produce dentine bonding agents and specialized resins for restorative and prosthetic dental applications, all designed for use in dental procedures.

Where is Kulzer, Inc. based?

Kulzer, Inc. is headquartered in the United States. The company focuses on developing and manufacturing dental materials and systems primarily for use in clinical and laboratory settings.

Which regulatory registries list Kulzer, Inc.’s devices?

Kulzer, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability for healthcare providers and regulators.

How are Kulzer, Inc.’s devices classified under medical device regulations?

Kulzer, Inc.’s devices fall under Class II medical device classification. This classification applies to products that generally pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as dental materials and systems used in restorative or prosthetic procedures.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: 4315 S. Lafayette Blvd., SOUTH BEND, IN, 46614
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1821514
DUNS Number: —

Catalogue (6131)

Page 78 of 123

Device	Model / Reference	Registries	Class	Status
Premium 8, A3.5 / XSL, CE	66007302	FDA UDI	Class II	Unknown
Artic 6, BL3 / L 25, CE	66970433	FDA UDI	Class II	Active
Mondial 6i, B3 / R2, CE	66970612	FDA UDI	Class II	Active
Basic 6, A3 / P22, CE	56739211	FDA UDI	Class II	Unknown
Mondial 8, BL2 / 30L, CE	66802209	FDA UDI	Class II	Active
Artic digital 6, A2 / TO30D, CE	66080293	FDA UDI	Class II	Active
Delara	66071545	FDA UDI	Class II	Active
Mondial 8, BL3 / 33L, CE	66801129	FDA UDI	Class II	Active
Artic	66080634	FDA UDI	Class II	Active
Artic digital 8, A3 / 20 degree-34 UD, CE	66983201	FDA UDI	Class II	Active
Premium 6, C3 / O2, CE	66006886	FDA UDI	Class II	Unknown
Delara	66071683	FDA UDI	Class II	Active
Artic 6, BL3 / S 20, CE	66970404	FDA UDI	Class II	Active
Venus Pearl	66048149	FDA UDI	Class II	Active
Artic digital 6, C2 / T15D, CE	66080485	FDA UDI	Class II	Active
Artic 8, D2 / 0 degree - 30 L, CE	66015230	FDA UDI	Class II	Active
Mondial 8i, B3 / 35L, CE	66973845	FDA UDI	Class II	Active
Mondial 6, B4 / T452, CE	66975580	FDA UDI	Class II	Active
Mondial 8i, B4 / 37L, CE	66973855	FDA UDI	Class II	Active
Mondial 6 DS, B1 / S443, CE	66985761	FDA UDI	Class II	Unknown
Artic digital 8, C2 / 10 degrees-30LD, CE	66080737	FDA UDI	Class II	Active
Artic digital 6, D3 / T35D, CE	66080575	FDA UDI	Class II	Active
Delara	66071665	FDA UDI	Class II	Active
Venus Pearl	66048094	FDA UDI	Class II	Active
Artic 6, C2 / TO 05, CE	66015011	FDA UDI	Class II	Active
Mondial 8i DS, A3 / 33L, CE	66986836	FDA UDI	Class II	Unknown
Mondial 6, A2 / S445, CE	66016887	FDA UDI	Class II	Active
Artic	66080685	FDA UDI	Class II	Active
Delara	66071426	FDA UDI	Class II	Active
Artic digital 6, A1 / TO40D, CE	66080272	FDA UDI	Class II	Active
Delara	660713620	FDA UDI	Class II	Active
Flexitime Heavy Tray 1x(2 X 50 Ml)	50034804	FDA UDI	Class II	Active
Mondial 8, D2 / 32 U, CE	66802186	FDA UDI	Class II	Active
Durafill VS	66000013	FDA UDI	Class II	Active
Mondial 6, A3.5 / L315, CE	66016945	FDA UDI	Class II	Active
Mondial 6i DS, A2 / R8, CE	66986244	FDA UDI	Class II	Unknown
Mondial 6, BL3 / S453, CE	66801059	FDA UDI	Class II	Active
Artic 6, D4 / T 15, CE	66015089	FDA UDI	Class II	Active
Signum composite	66020012	FDA UDI	Class II	Active
Mondial 6, A2 / T515, CE	66016881	FDA UDI	Class II	Active
Mondial 6, A4 / T450, CE	66016962	FDA UDI	Class II	Active
Delara	66071556	FDA UDI	Class II	Active
Artic digital 8, C1 / 10 degrees-30 UD, CE	66080726	FDA UDI	Class II	Active
Venus Pearl	66048164	FDA UDI	Class II	Active
Mondial 6i DS, A3 / R8, CE	66986266	FDA UDI	Class II	Unknown
Artic digital 6, D3 / L05D, CE	66080581	FDA UDI	Class II	Active
iBOND TOTAL ETCH BOTTLE SAMPLE 1 x 2ML	66048262	FDA UDI	Class II	Active
Signum composite	66020020	FDA UDI	Class II	Active
Charisma	66000111	FDA UDI	Class II	Active
Premium 6, D3 / R6, CE	66007089	FDA UDI	Class II	Unknown

Related Companies

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FDA Establishments (2)

Establishments registered with the FDA under this company group, matched by name.

Kulzer Gmbh HANAU Hesse · DE FEI 3005665377
Kulzer SRL Sacalaz-Judet Timis · RO FEI 3011203516